Par gets tentative FDA approval for generic Dostinex

By Angela McDaniels

Seattle, Dec. 1 - Par Pharmaceutical Cos. Inc. said the U.S. Food and Drug Administration granted tentative approval for the company's Abbreviated New Drug Application for cabergoline tablets.

Cabergoline is the generic version of Pfizer's Dostinex and is used for the treatment of hyperprolactinemic disorders. Annual U.S. sales of Dostinex exceed $80 million, the company said.

Par said it is the first generic company to receive a tentative approval for cabergoline and expects to launch the product following expiration of Pfizer's patent on Dec. 29.

A tentative approval does not allow the applicant to market the generic product and postpones the final approval until all patent and exclusivity issues have expired.

Par is based in Spring Valley, N.Y., and develops generic pharmaceuticals through its principal subsidiary, Par Pharmaceutical. The company is also developing an additional line of branded pharmaceutical products for specialty markets.

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